Study of the Effect of Diabetes on the Incidence and the Extent of Coronary Artery Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01585948|
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : March 26, 2020
|Condition or disease|
|Patients Undergoing Coronary Angiography|
|Study Type :||Observational|
|Actual Enrollment :||1104 participants|
|Official Title:||The Role of Newer and Traditional Risk Factors in the Development, Extent and Manifestation of Coronary Artery Disease|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||March 2020|
All patients undergoing coronary angiography who are diabetics.
No diabetes mellitus
All patients undergoing coronary angiography that are non-diabetics.
Coronary angiography patients
Diabetics and non-diabetics with or without known CV disease who are admitted in the Department of Cardiology in the University Hospital of Ioannina and the Catheterization Laboratory of 1st IKA Hospital in Athens and undergo coronary angiography for clinical purposes will be studied. The study will include subjects who 1) have suspected CAD and undergo a scheduled diagnostic angiogram for clinical reasons, and 2) are hospitalized because of an acute coronary syndrome and thus undergo diagnostic angiography (with or without previous history of CAD).
- The incidence and extent of coronary artery disease between diabetics and non-diabetic patients. [ Time Frame: Up to four years on average. ]We will investigate the incidence, extent and clinical manifestation of coronary artery disease in diabetics and non-diabetics undergoing coronary angiography for clinical reasons.
- The incidence and extent of coronary artery disease via coronary angiography scores and related biochemical and demographical risk factors. [ Time Frame: Up to 4 years on average. ]To associate the incidence, extent and clinical manifestation of coronary artery disease with classic demographic risk factors (such as smoking, alcohol consumption, physical exercise, arterial hypertension, family history of diabetes mellitus or coronary artery disease) and common biochemical risk factors (such as fasting glucose levels, urea, creatinine, HbA1c%, uric acid, total cholesterol, HDL, LDL, triglycerides, VLDL, glomerular filtration rate - GFR).
- The incidence, extent and clinical manifestation of coronary artery disease and the circulating levels of hs-CRP, adipokines and RAGEs. [ Time Frame: Up to 4 years on average. ]To associate the incidence, extent and clinical manifestation of coronary artery disease with systemic inflammatory status assessed by hs-CRP levels, circulating adipokines (adiponectin, resistin) and the receptors of advanced glycation end products (sRAGE and esRAGE).
- TCF7L2 gene polymorphims and the incidence and extent of coronary artery disease. [ Time Frame: Within a maximum period of 4 years. ]To associate the incidence, extent and clinical manifestation of coronary artery disease with the rs7903146 single nucleotide polymorphism of TCF7L2 gene, that has been strongly associated with diabetes mellitus development.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585948
|2nd Department of Cardiology, University Hospital of Ioannina|
|Ioannina, Greece, 45110|
|Principal Investigator:||Katerina Naka, As Professor||University of Ioannina|